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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05117411
Other study ID # 09/21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 30, 2020

Study information

Verified date November 2021
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography


Description:

Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery. It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 30, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria: - age older than 60 years - diagnosis of pseudophakic cystoid macular oedema - treatment-naïve for pseudophakic cystoid macular oedema - absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration) Exclusion Criteria: - age younger than 60 years - No diagnosis of pseudophakic cystoid macular oedema - previous treatment for pseudophakic cystoid macular oedema - presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
OCTA and pseudophakin cystoid edema
Patients underwent OCT angiografia after cataract surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Outcome

Type Measure Description Time frame Safety issue
Primary OCTA and pseudophakic cystoid macular oedema The parameters analyzed by OCTA three months after surgery are:
Vessel density (%) of superficial capillary plexus, deep capillary plexus, coriocapillary plexus in macular region Vessel density (%) of radial peripapillary capillary plexus in papilllary region
3 months
See also
  Status Clinical Trial Phase
Completed NCT03404323 - "Cataract Surgery in Eyes With Epiretinal Membrane" N/A